OPD5 / Oncopeptides - LARVOL DELTA

U.S. Food and Drug Administration removes clinical hold of Oncopeptides’ pipeline drug OPD5 (Oncopeptides Press Release) - "Oncopeptides AB...announces the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on Oncopeptides’ next-gen drug OPD5. Based on the company’s proprietary Peptide Drug Conjugate (PDC) platform, OPD5 is a follow-on molecule to Oncopeptides’ flagship drug melflufen (branded in Europe as Pepaxti) with a potentially improved risk/benefit profile and enhanced intellectual property protection. OPD5 would initially target multiple myeloma and could potentially be expanded with other indications and diseases over time....As a next step, Oncopeptides will continue to prepare for a new clinical study, OP-502, to assess the safety, tolerability and efficacy of OPD5."

FDA event • Multiple Myeloma

COAST: A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Oncopeptides AB; N=42 ➔ 0; Suspended ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

COAST: A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=42; Suspended; Sponsor: Oncopeptides AB; Recruiting ➔ Suspended

Clinical • Trial suspension • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

COAST: A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Oncopeptides AB

Clinical • New P1 trial • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

[VIRTUAL] COAST (OP-501): FIRST IN MAN PHASE I MULTICENTER STUDY EVALUATING OPD5 AS A MYELOABLATIVE CONDITIONING REGIMEN IN RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM) (EBMT 2021) - " As OPD5 has similar preclinical pharmacokinetic and lipophilic properties as melflufen, it is of significant medical interest to investigate the benefit-risk profile of OPD5 as a conditioning regimen in patients where salvage ASCT is not currently considered standard of care. Findings from this first-in-man study will potentially demonstrate the value of OPD5 as a myeloablative therapy followed by stem cell support, justifying further clinical development."

Clinical • P1 data • Hematological Malignancies • Immune Modulation • Inflammation • Mucositis • Multiple Myeloma • Oncology • Transplantation

[VIRTUAL] COAST (OP-501): FIRST IN MAN PHASE I MULTICENTER STUDY EVALUATING OPD5 AS A MYELOABLATIVE CONDITIONING REGIMEN IN RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM) (EBMT 2021) - " As OPD5 has similar preclinical pharmacokinetic and lipophilic properties as melflufen, it is of significant medical interest to investigate the benefit-risk profile of OPD5 as a conditioning regimen in patients where salvage ASCT is not currently considered standard of care. Findings from this first-in-man study will potentially demonstrate the value of OPD5 as a myeloablative therapy followed by stem cell support, justifying further clinical development."

Clinical • P1 data • Hematological Malignancies • Immune Modulation • Inflammation • Mucositis • Multiple Myeloma • Oncology • Transplantation

[VIRTUAL] COAST (OP-501): FIRST IN MAN PHASE I MULTICENTER STUDY EVALUATING OPD5 AS A MYELOABLATIVE CONDITIONING REGIMEN IN RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM) (EBMT 2021) - " As OPD5 has similar preclinical pharmacokinetic and lipophilic properties as melflufen, it is of significant medical interest to investigate the benefit-risk profile of OPD5 as a conditioning regimen in patients where salvage ASCT is not currently considered standard of care. Findings from this first-in-man study will potentially demonstrate the value of OPD5 as a myeloablative therapy followed by stem cell support, justifying further clinical development."

Clinical • P1 data • Hematological Malignancies • Immune Modulation • Inflammation • Mucositis • Multiple Myeloma • Oncology • Transplantation

[VIRTUAL] COAST (OP-501): FIRST IN MAN PHASE I MULTICENTER STUDY EVALUATING OPD5 AS A MYELOABLATIVE CONDITIONING REGIMEN IN RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM) (EBMT 2021) - " As OPD5 has similar preclinical pharmacokinetic and lipophilic properties as melflufen, it is of significant medical interest to investigate the benefit-risk profile of OPD5 as a conditioning regimen in patients where salvage ASCT is not currently considered standard of care. Findings from this first-in-man study will potentially demonstrate the value of OPD5 as a myeloablative therapy followed by stem cell support, justifying further clinical development."

Clinical • P1 data • Hematological Malignancies • Immune Modulation • Inflammation • Mucositis • Multiple Myeloma • Oncology • Transplantation

Oncopeptides: INTERIM REPORT Q3 2020 (PRNewswire) - "Patient enrolment for the phase 1/2 study in AL-amyloidosis began, this is the first study with melflufen in an indication outside multiple myeloma. The phase 2 PORT study evaluating alternative administration of melflufen and dexamethasone in multiple myeloma started. Oncopeptides entered into a €40 M loan agreement with the European Investment Bank (EIB). An IND application was submitted to the FDA to initiate clinical studies with OPD5, Oncopeptides' second drug candidate."

Enrollment open • Financing • IND • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology